Ethical aspects of the EURAMY project
The aims of the project cover a broad area from chemical and biophysical experiments to diagnosis and treatment of patients.
The diagnostic procedures involve that tissue specimens are taken from diseased indivudals. Development of new treatment strategies should finally be tested on individuals suffering from severe diseases (amyloidoses). The project has to take the ethical consequences into consideration, which means approval both from the individuals and from independent ethical boards. In contrast, the experimental studies do not need ethical approval, simply as they increase knowledge, which should always be considered to be in the interest of both good science and afflicted individuals.
All the groups in the EURAMY project follow international declarations, most importantly the declaration of Helsinki and the Oviedo convention. Moreover, there is a range of European laws and directives, as well as national declarations which apply, all of which are followed.
It should be underscored that all project leaders have the responsibility to balance harm against scientific value and that only experiments are performed, where independent ethical boards have been convinced that the scientific value overrides harm or negative side effects.
The procedures for biopsies are not harmonized on the European level, and here national laws apply. New drugs cannot be tested on human beings, before information is gathered of potential mechanisms and possible beneficial as well as negative side effects. Therefore, new drug candidates are first tested in cell cultures for basic studies. Later, promising candidates are tested on animal models, in this project on transgenic mice, which has to be accepted by an animal ethical review board. To minimize suffering of animals the 3R principles apply (refine, reduce and replace). For this purpose also a fruit fly model has been implemented, which will allow studies both on mechanisms and potential side effects.
Therefore, when clinical studies start, knowledge has been generated, which adds a positive ethical value to the scientific knowledge gained. Only drug candidates will be tested, where the project leaders have presented evidence, that they have the potential for positive effects on disease development and the quality of life of the patients. In addition, a close monitoring of the toxicity and side effects of the new drugs is warranted in order to secure a positive balance of the benefit/risk ratio.